Trials / Active Not Recruiting
Active Not RecruitingNCT05914064
Gravitas Feeding Tube System Placement Validation in Neonates
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Gravitas Medical, Inc. · Industry
- Sex
- All
- Age
- 0 Weeks – 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gravitas FT and Gravitas FT Monitor guidance | FT placed with guidance from the Gravitas FT system |
Timeline
- Start date
- 2023-10-27
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
- First posted
- 2023-06-22
- Last updated
- 2025-11-24
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05914064. Inclusion in this directory is not an endorsement.